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The magazine for those living with food allergies, celiac disease, asthma and pollen allergies.Fri, 09 Dec 2016 17:03:31 +0000en-UShourly1http://wordpress.org/?v=4.3.1Allergy Shots Safety Confirmed in New Study That Calls Proposed Rules into Questionhttp://allergicliving.com/2016/04/14/allergy-shots-safety-confirmed-in-new-study-that-calls-proposed-rules-into-question/
http://allergicliving.com/2016/04/14/allergy-shots-safety-confirmed-in-new-study-that-calls-proposed-rules-into-question/#commentsThu, 14 Apr 2016 12:57:35 +0000http://allergicliving.com/?p=40899A new study confirming the safety of current allergy shots practices, calls into question the need for proposed new rules that the United States Pharmacopeia (USP) has proposed as a means to protect against infections.

In the study, conducted by researchers at Massachusetts General Hospital and published in The Journal of Allergy and Clinical Immunology (JACI) in April 2016, researchers analyzed 10 years’ worth of data from two large Boston hospitals, covering 3,242 patients who have collectively received a total of 136,322 allergen immunotherapy (AIT) injections.

Researchers said that, of the “86 episodes of infections occurring within five days of receiving an allergy shot,” none were found to be related to the treatment.

“Out of the many millions of injections, administered to millions of patients, over several decades, there are no reported infections,” Long said in a AAAAI news release. “In this study, our team also found zero reported infections due to allergy shots. It’s clear that the sterility and safety practices in place during the study period are adequate in preventing adverse infectious outcomes related to the preparation and administration of AIT,” he added.

The safety record of the allergy shots extraction process, which is done in an allergist’s office using aseptic techniques, is well-established and has been in clinical practice for more than 100 years. In addition to improving access and availability for patients, allergists opposed to the proposed USP rules say the existing process also allows them to monitor patients closely for reactions for 30 minutes after receiving an allergy injection, and allows for continuity of care.

AAAAI says that USP’s proposed stringent protocols for sterility and engineering control were designed to keep people safe for intravenous, spinal and other forms of systemic administration rather than under-the-skin injection. Shorter expiration dates under the new USP proposed rules would further complicate the ability of allergists to deliver the treatment: It would be mean “more allergy shots, more cost, less chance of reaching an effective dose, and increased risk of the patient for allergic reaction to allergy shots,” allergist and AAAAI fellow Dr. Andrew Murphy told Allergic Living in January.

“Even though there are no reports of infection resulting from allergy shots, proposed United States Pharmacopeia (USP) regulations would restrict allergen compounding and drastically limit patients’ access to allergy shots,” concluded Long.

To learn more and sign a AAAAI petition to protect access to allergy shots, click here.

AAAAI, the world’s leading allergist organization, has launched a petition at Change.org, that is gathering thousands of supporters opposed to the changes. The call to action of the campaign says this: “Help the AAAAI save patient access to allergy shots. Sign this petition to let United States Pharmacopeia know they should keep the existing requirements in place.”

Allergist and AAAAI fellow Dr. Andrew Murphy told Allergic Living by email that the changes, which are proposed by the United States Pharmacopeia (USP), are unnecessary, and the reason given for the proposal – to reduce the risk of infection when patients are receiving allergy shots – isn’t backed up by medical evidence.

“For over 100 years, allergists have been compounding allergen extracts in their practices and there has never been a report of an infectious complication,” wrote Murphy, who’s been working behind the scenes to raise awareness about the consequences of USP’s proposals.

“These proposed new rules are incredibly onerous and probably will be cost prohibitive for AAAAI physicians to undertake,” he said. “The consequence of this is that physicians will have none to very limited options for getting allergen extract.”

And while the risk of allergy shots no longer being available at all in allergists’ offices is the prime consequence Murphy points to, he also drew attention to the details of the USP’s proposed changes, and how they might affect patients’ treatment regimens:

“The USP is proposing shorter expiration dates for allergen extracts,” he noted. “What does this mean? More allergy shots, more cost, less chance of reaching an effective dose, and increased risk of the patient for allergic reaction to allergy shots.”

Murphy also said the benefits of allergy shots as a treatment go well beyond symptom relief, helping prevent further allergies and even asthma in some patients, in addition to helping reduce costs.

“Allergy shots can prevent the development of more allergies and in the right patient can prevent the development of asthma,” Murphy wrote. “Importantly, data from a study done in Florida demonstrated that appropriate treatment with allergen immunotherapy resulted in significant decreases in health-care costs for patients.” Murphy says that USP has not provided any clear reasons as to why this proposed change is needed.

So what can people do to support the AAAAI’s position on protecting easy access to allergy shots? Murphy says the best step right now is to sign the AAAAI petition calling for the group to leave the regulations as is.

“The bottom line,” Murphy concluded, ” is that the changes proposed by USP will profoundly and negatively impact allergy care in the U.S. These changes are not justified, and will ultimately harm patients.”

This article first appeared in Allergic Living magazine. See the newer article on the therapy failing in a crucial study here.

THE ANCIENT Egyptians were said to revere the cat, glorifying it in hieroglyphs, depictions of deities and artwork. While today’s domestic kitty may not enjoy the same royal treatment, the feline still wields serious power: just being in the same room as one can trigger itching, coughing, wheezing and even a full-on asthma attack in the millions who have cat allergy.

The American Academy of Allergy, Asthma and Immunology says the condition affects an estimated 50 million Americans, including the 30 percent of those with allergic asthma who list cat dander as a key trigger.

Other than simply avoiding cats, immunotherapy, or allergy shots, is the only current treatment option for this allergy. The idea here is to re-train the immune system to accept the cat’s allergy-inducing protein rather than react to it as a dangerous invader.

To do so, the doctor injects small amounts of cat protein extract into the body over several visits, slowly increasing the dosage and then staying at a target level for three to five years. The hope is to achieve desensitization, or at the very least, greatly reduced symptoms.

The process is far from ideal. Not only does it require close to 100 injections, it is incredibly time-consuming, with untold hours spent at the doctor’s office. Not surprisingly, many patients simply quit going. Immunotherapy also always carries a reasonable risk of reaction, since the very thing a person is allergic to is being injected into the body. Anaphylaxis to immunotherapy, while uncommon, certainly has been reported, which is why patients are meant to wait at least half an hour in the doctor’s office after receiving an injection.

This is all that’s available today. However, the big news in the allergy and asthma research community is that a new, quick, and seemingly effective treatment for cat allergy looms large on the horizon, holding the promise of an end to the widespread grief.

Reports from a recently completed clinical trial speak for themselves. After just four shots of the new product – named Cat-SPIRE – patients experienced a significant decrease in symptoms when exposed to cat allergens. Not four shots per month or year, but just four shots in total, each taken one month apart. Two years later, the results were largely the same.

“That took us all by surprise,” says Mark Larché, an immunologist and professor of medicine at McMaster University in Hamilton, Canada. “To get a two-year effect after just one course of treatment, particularly when it’s only four injections, that’s very encouraging.” Larché is the co-founder of Circassia Ltd., a British biotech firm that is spearheading the product’s development along with the Canadian company Adiga Life Sciences, which is jointly owned by Circassia and McMaster University.

The key to Cat-SPIRE is the science behind the shot. Circassia scientists take the allergenic cat protein, called Fel d1, and break it down into basic parts called peptides. The building blocks of proteins are called amino acids, and peptides are strings of two or more amino acids. The Fel d1 protein is normally 162 amino acids long, while Cat-SPIRE contains seven synthetic peptides, each 15 amino acids in length, and each hand-picked to generate the desired response.

“Currently available immunotherapy basically takes the thing you’re allergic to and injects it into you,” says Steve Harris, CEO of Circassia and director of Adiga Life Sciences. Cat-SPIRE, he explains, was created by zeroing in on parts of Fel d1 that promote a regulatory, or non-allergic, immune response. By using fragments of Fel d1 created in a lab as opposed to the entire protein, fewer shots are needed, reactivity is lessened, increases in dosage are not required, and so far, the results have been impressive.

Patients have now been recruited for a final (or phase 3) trial that will confirm the shot’s effectiveness and also test whether giving eight injections instead of four makes any difference. About 1,400 cat-allergic individuals between the ages of 12 and 65 have enrolled in the trial, which is taking place in multiple sites across the United States, Canada and Russia over the next year.

Yet researchers already know that the shot won’t be equally effective for everyone. Dr. Harold Nelson, the principal investigator of the phase 3 trial, is quick to point out that patients in the previous trial showed an average symptom reduction of 50 percent. This suggests that Cat-SPIRE probably has a strong effect for many individuals, while others will likely benefit to a lesser degree.

Next: How study participants are doing now

]]>http://allergicliving.com/2015/02/18/a-shot-at-a-cure-for-cat-allergy/feed/0Allergy Experts Assess State of Immunotherapyhttp://allergicliving.com/2013/07/11/allergy-experts-assess-state-of-immunotherapy/
http://allergicliving.com/2013/07/11/allergy-experts-assess-state-of-immunotherapy/#commentsThu, 11 Jul 2013 23:41:46 +0000http://allergicliving.com/?p=18368The American Academy of Allergy, Asthma & Immunology and the European Academy of Allergy and Clinical Immunology have collaborated to produce a comprehensive review of allergy immunotherapy. The report focuses on the current state of both subcutaneous (allergy shots) and sublingual (allergy drops or tablets) immunotherapy.

The report, which was officially endorsed by both academies and written by a panel of experts selected by each, includes a thorough review of where immunotherapy stands as a treatment, how it can be improved, and what its future holds.

The authors note that both drops and shots have been shown to be effective for environmental allergies such as allergic asthma, rhinitis and atopic dermatitis (eczema). Only injections have been effectively used for insect venom allergy. Studies in the past had looked at using shots for peanut allergy, but anaphylactic reactions occurred and the experiments were abandoned.

More recently, clinical trials have been conducted analyzing the potential for sublingual therapy for food allergies, with promising results. More research is needed, however, before this becomes a viable treatment for food allergy.

The consensus report compares the two types of immunotherapy examining side effects, dosing and how effective they are. For subcutaneous therapy for environmental allergies, side effects were found to range from local and mild to systemic. Systemic reactions can include anaphylaxis, although this is fortunately uncommon. (In an AAAAI/EAACI survey, 0.1 percent of injections led to systemic reactions between 2007 and 2009.)

This potential for a severe reaction is the reason behind guidelines that recommend any patient receiving allergy shots remain under supervision in the doctor’s office for 30 minutes after the treatment.

By comparison, the sublingual immunotherapy side effects were generally mild. The most common side effects were local reactions, including itching and minor swelling. These side effects usually only occurred near the beginning of the treatment, and tended to resolve on their own as treatment continued.

No systemic reactions have been reported with this form of immunotherapy. An advantage with the oral drops or tablets is that once proper dosing is established, the treatment can be taken at home without the need for monitoring in the allergist’s office.

In terms of effectiveness, the authors note that after several years of treatment, both forms of immunotherapy result in the individual being desensitized to environmental allergens for seven to 12 years.

The report also finds that both therapies appear to reduce the chance of rhinitis developing into allergic asthma, or of new allergies developing in people who are sensitive to just one allergen.

The authors raise some issues that still require attention. One of the biggest is that researchers still don’t know why both types of immunotherapy are highly effective for some patients, yet have little or no beneficial effect for others.

The report also finds that patients commonly don’t adhere to immunotherapy regimens, likely because of the long duration of the treatment and the number of shots or tablets required.

The authors conclude that, despite its effectiveness, immunotherapy “remains a niche treatment secondary to symptomatic drugs because of its cost, long duration of treatment, and concerns regarding safety and effectiveness.” They see the need for standardized approaches and regulation, and further research to predict patient responses to move immunotherapy successfully forward.

On April 3, Dr. Mehmet Oz hosted a segment on his TV show called “How to Survive the Allergy Epidemic”. In keeping with many news reports released this spring, Dr. Oz declared: “This year, you’re going to feel even more miserable than ever before.”

New York allergist and Allergic Living contributor Dr. Clifford Bassett was invited to help explain to viewers why this may be. He said that climate change factors, such as warm seasons starting earlier and ending later, are to blame. He also noted that tree pollen and grass pollen seasons can overlap resulting in a “pollen bomb” that can cause misery for allergy sufferers.

Dr. Oz did an excellent job explaining how certain weather patterns can cause what allergy specialists and botanists now call ‘the priming effect’ – where pollen levels rise, fall and rise again in late winter and early spring. When it’s unseasonably warm, plants begin producing pollen early. When the temperature drops again, they stop, and then begin again once the warmer weather returns. In pollen-sensitive individuals, this can cause worsened allergy symptoms that are tougher to control because their immune system has been ‘primed’ for pollen allergens.

The topic of conversation then moved to treatment. Most medications for spring allergies work by blocking histamine receptors, so the histamine in one’s body has nowhere to bind to and cause symptoms. These treatments are effective for most people, but they treat the symptoms but not the underlying allergic disease. Upon each re-exposure, the symptoms will have to be blocked again.

This is why doctors often recommend immunotherapy, or allergy shots, in which a small amount of the allergen (i.e. pollen) is injected into a sensitized individual on multiple occasions over a long period of time. The goal is to allow the patient to build tolerance to the allergen and eventually no longer be sensitized to it.

The trouble with this traditional type of immunotherapy, which Dr. Bassett noted has been available for almost 100 years, is just that – the trouble: injections are required several times before each allergy season for several years, resulting in many, many hours in the allergist’s office.

Fortunately, Dr. Bassett informed Dr. Oz’s audience that sublingual immunotherapy (SLIT), which is a type of immunotherapy that uses under-the-tongue tablets or drops instead of needles, is gaining ground. It is far less invasive: once an allergist determines the proper dosage, a patient can actually conduct this immunotherapy by themselves, at home.

While not yet approved by the FDA, several clinical trials have demonstrated that this type of treatment can be effective, and it has been available in Europe for years. One brand, Oralair, was recently approved for prescription use in Canada.

]]>http://allergicliving.com/2013/04/10/dr-oz-on-the-allergy-epidemic/feed/0New Grass Allergy Treatments Almost Herehttp://allergicliving.com/2013/03/28/new-grass-allergy-treatments-almost-here/
http://allergicliving.com/2013/03/28/new-grass-allergy-treatments-almost-here/#commentsThu, 28 Mar 2013 16:24:36 +0000http://allergicliving.com/?p=16487
Two new grass allergy tablets, one available in Canada and one soon to become available in the United States, show promise as alternatives for the traditional and time-consuming course of allergy shots. These tablets are taken once a day, under the tongue where they dissolve and take effect.

One of the tablets, known as Oralair, recently became available by prescription in Canada, but not the United States. This pill has proven effective in international studies, and is now approved by Health Canada.

Another tablet, known as Grazax in Europe, has been submitted to the FDA in the United States for final approval. Unfortunately, the tablet (which will have a different brand name in the U.S.) most likely won’t become available until next year’s grass season at the earliest.

When it comes to grass allergy, taking antihistamines does the job for some people. But allergists have traditionally steered those with more severe symptoms and asthma toward immunotherapy, also known as allergy shots. The tablets are a new form of this therapy – called sublingual immunotherapy, or SLIT, because the dose is taken under the tongue.

Although it’s recommended to begin taking these tablets four months before allergy season begins, they have been known to show significant improvement after being taken for as little as one month. This is far less invasive and time-consuming than traditional immunotherapy: instead of visiting an allergist several times to get your shots, you can simply place a tablet under your tongue and allow it to dissolve.

Sublingual immunotherapy is actually not so new. For years now, researchers have been studying it, not just for grass allergy but potentially for food allergy as well. It works with the same principle as traditional allergy shots: introduce tiny amounts of the specific allergen into the patient’s system (in this case, via drops), with the goal of building toward tolerance.

Spring and early summer present a constant dilemma for people allergic to grass. It’s a choice between dodging pollen behind tightly sealed windows, or engaging in a battle with the blades, hoping antihistamines, nasal sprays and eye drops will keep the worst of the symptoms at bay.

A lot of us are making this daily choice between nose-streaming suffering and indoor boredom. It’s estimated that about 26 percent of North Americans are sensitized to either Timothy or rye grasses, and 18 percent to Bermuda grass, often used on golf courses.

Allergy shots have long been an option for those who can’t bear all the congestion and mucus any longer, but they require a serious commitment to needles and doctor’s visits, week after week, allergy season after allergy season, for several years.

For the moment, those shots are the only game in town. But that may be about to change. Needles may soon give way to small tablets, placed under the tongue and allowed to dissolve for about a minute. And, impatient people, rejoice: the tablets – called sublingual immunotherapy or SLIT – may significantly improve hay fever symptoms within a month. The best news? Two SLIT pills have recently completed the final phase of testing in the U.S. and their makers getting ready to apply for regulatory approval.

Dr. Linda Cox, a Fort Lauderdale, Florida allergist who organized a large study for one of the drugs, has spent years looking at the limitations and safety of immunotherapy for environmental allergens like grasses. She points to European research that followed patients who took grass SLIT tablets to note how life-changing the drug can be. Years after patients stopped taking the tablets, the protective effects still lingered. “No [other] medication does that,” Cox says. “You can’t take a drug for a season and expect the next season it will have [still] fixed your problem.”

With pollen seasons becoming longer in many areas, such therapies could be all the more important, as allergy sufferers are faced with the threat of even longer stretches of congested misery.

The Contenders

One of the SLIT drugs is called Oralair in Europe, and is produced by the French company Stallergenes. It contains extracts from five northern grasses, including orchard grass, Kentucky bluegrass, perennial ryegrass, sweet vernalgrass and Timothy grass, most of which are found in nearly every North American state and province. Like other immunotherapies, the drug works by repeatedly exposing the body to tiny amounts of allergen over several months, which helps to desensitize the allergy sufferer just in time for a spring blast of pollen.

In a U.S. study of Oralair, 473 grass-allergic adults in several northern and central states got either the drug or a placebo for six months. Researchers found a 28 percent improvement in allergy symptoms and medication use compared to the group getting the sugar pills. Oralair was particularly good at relieving itchy and watery eyes, and patients also said they slept better.

The other tablet that could soon be on North Americans’ relief radar is known as Grazax in Europe (where SLIT tablets have been on the market since 2006). Danish company ALK makes the tablet, but drug-manufacturer Merck is spearheading the American research and push for approval. Unlike Oralair, Grazax focuses its immunological attack on just one pollen: Timothy grass, which is found everywhere in North America except Nunavut and Puerto Rico.

In one U.S. study of Grazax, adults showed about a 20 percent improvement in symptoms. In another, children’s allergy symptoms improved by 26 percent. “If somebody takes Grazax, and uses nasal steroids and antihistamines on top of it, then this would be by far the most effective

Immunotherapy is a form of treatment, commonly known as allergy shots, in which a patient with allergic rhinitis gets controlled exposure to allergens through injections. It will not be the first course of treatment. In immunotherapy, a doctor raises the allergen dose in your shots over a number of months and years – the intent is that as the dose rises, you become less sensitive to allergens.

Who should get allergy shots?

First, your allergist will take a history, do an examination including skin-prick tests to determine what you are allergic to, and then will prescribe medications. If you’re still suffering even with medication, allergy shots may be the next step. Candidates for this treatment are usually people who are no longer helped by allergy medications and those who have serious rhinitis symptoms for prolonged periods of time.

If you haven’t had allergies for long, you are more likely to be responsive and experience longer-lasting benefits. Children, however, should have had seasonal symptoms for at least two years before being considered candidates, says Dr. Eric Leith, an allergist based in Oakville, Ontario. The child should be old enough to understand what’s going on, he says, “and if a reaction occurs, they must be able to express that.”

Allergist Dr. Harold Kim says about 5 to 10 per cent of patients receiving immunotherapy have skin, breathing or gastrointestinal reactions. Only about 1 to 3 per cent have more severe reactions. While anaphylaxis is rare, “immunotherapy can be life-threatening,” cautions Leith. “You should be waiting in the doctor’s office for half an hour [after the treatment] to make sure you are not reacting.” If you have asthma, Leith stresses that it must be under control or the shots “may accentuate the asthma.”

How long does immunotherapy treatment last?

Immunotherapy can take years to carry out. Patients receive one to two shots a week of minimal amounts of their allergen for about six months, until they reach their “maintenance dose,” which means symptoms have improved. Then, a monthly dose is required to keep the allergies under control. Treatment can take up to five years, but the benefit of immunotherapy is that it may have a lasting effect even after the shots have stopped. Leith says there have been cases in which patients have seen their symptoms disappear completely.

First published in Allergic Living magazine.To subscribe or order a back issue, clickhere.